Loading clinical trials...

The PROTEMBO C Trial | Clinical Trials | Clareo Health

COMPLETEDNA

The PROTEMBO C Trial

Cerebral Protection in Transcatheter Aortic Valve Replacement - The PROTEMBO C Trial

NCT04618718•Protembis GmbH

Summary

The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve stenosis indicated for TAVR.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The heart team recommends transcatheter valve aortic valve replace consistent with the 2017 ESC/EACTS Guidelines for the management of valvular heart disease.
•2. Compatible left subclavian artery (≥ 4 mm diameter) without significant stenosis (\> 70%) and distance between the origin of left subclavian artery and valve plain of ≥ 90mm as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality.
•3. The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits.
•4. The subject is able to provide informed consent, has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the relevant regulatory authority of the respective clinical site.
•5. Subject is a minimum of 18 years of age.

Exclusion Criteria

•General:
•1. Left upper limb vasculature in the left extremity precluding 6Fr sheath radial / brachial / subclavian access.
•2. Inadequate circulation to the left extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse.
•3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
•4. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
•5. Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
•6. Aortic valve is a congenital unicuspid or bicuspid valve.
•7. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
•8. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
•9. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
+41 more criteria

Locations (8)

Krankenhaus der Barmherzigen Brüder Trier

Trier, Rhineland-Palatinate, Germany

Herzzentrum Leipzig-Universitätsklinik für Kardiologie-Helios

Leipzig, Saxony, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein (UKSH)

Lübeck, Schleswig-Holstein, Germany

Pauls Stradins Clinical University Hospital

Riga, Latvia

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Szpital Kliniczny Przemienienia Panskiego Poznan University of Medical Sciences

Poznan, Poland

Department of Interventional Cardiology Warsaw Institute of Cardiology

Warsaw, Poland

Key Dates

Start Date

July 31, 2020

Primary Completion Date

November 23, 2022

Completion Date

November 23, 2022

Last Updated

May 8, 2025

Enrollment

ACTUAL participants

Conditions

Valvular Heart Disease

Interventions

cerebral embolic protection during TAVR

DEVICE

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

NCT07462260

Pulmonary HypertensionRheumatic Valvular Heart Disease

View study

RECRUITING

Prospective Evaluation of AI-ECG for SHD Detection

NCT07057466

Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)Pulmonary Hypertension (Diagnosis)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The PROTEMBO C Trial

Inclusion Criteria

Exclusion Criteria

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Prospective Evaluation of AI-ECG for SHD Detection

PPG to Predict Ejection Fraction and Other Echographic Data in the General Population

Abbott Structural Heart Device Registry

Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement

Screening of Valvular Heart Disease Using Single-channel Electrocardiogram